← The record

ProgesteroneCrinone

Recommended Women's healthAuthority RequiredNot applicable line 💬 consumer voice

Luteal phase support as part of an assisted reproductive technology (ART) treatment cycle for infertile women.

8
Submissions
2 resub
2014–24
On the record
ICER range
Cost-min
Cost basis

Decisions on record

10 decisions
  • Meeting Nov 2024 Recommended Menopausal hormone therapy
  • Meeting Jul 2024 Recommended Luteal phase support for assisted reproductive technology
  • Meeting Jul 2024 Noted Assisted reproductive technology
  • Meeting Jul 2022 Recommended Infertility, luteal phase support in assisted reproductive technology treatment
  • Meeting Nov 2021 Recommended Prevention of preterm birth
  • Meeting Nov 2020 Recommended Prevention of preterm birth
  • Meeting Nov 2020 Recommended Prevention of preterm birth
  • Meeting Jul 2016 Recommended Assisted reproduction
2 earlier decisions
  • Mar 2016 Not recommended Assisted reproduction
  • Mar 2014 Recommended Endometrin® Ferring Pharmaceuticals Pty Ltd Assisted reproductive therapies To request a PBS listing as part of Section 100 IVF/GIFT Program for luteal phase support in patients who are receiving medical treatment as described in items 13200 or 13201 in the Medicare Benefits Schedule. The luteal pha

Access path

8 submissions · public record
  1. TGA registered · Crinone

    TGA label narrower than the PBS population

  2. Mar 2014
    Recommended

    vs progesterone gel (Crinone) and progesterone pessaries…

  3. Mar 2016
    Not recommended

    Cost-minimisation analysis not conducted against the appropriate comparator (should be progesterone pessary, the…

  4. ↻ resubmitted
    Jul 2016
    Recommended · restricted

    Comparator changed: progesterone pessary (progesterone 8% vaginal gel also considered) →…

  5. Nov 2020
    Recommended · restricted

    Comparator changed: progesterone pessary (Oripro) → best supportive care (standard of…

  6. Nov 2020
    Recommended · restricted

    Comparator changed: progesterone pessary (Oripro) → best supportive care (standard of…

  7. Nov 2021
    Recommended

    Comparator changed: Standard of Care (SOC) → Utrogestan (progesterone 200 mg soft capsule)

  8. Jul 2022
    Recommended · restricted

    Comparator changed: Utrogestan (progesterone 200 mg soft capsule) → Crinone 8% (90 mg)…

  9. Jul 2024
    Recommended · restricted

    Comparator changed: Crinone 8% (90 mg) progesterone vaginal gel → progesterone capsule…

  10. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended the Authority Required (STREAMLINED) listing of progesterone capsule 300 mg (Utrogestan) BID on the basis it should be available only under special arrangements covered under the PBS section 100 (IVF Program) for LPS as part of an ART treatment cycle.PSD · Jul 2024
6.2 The PBAC did not consider it appropriate to cost-minimise based on an equivalent price per day of treatment. The PBAC advised that the CMA should be calculated at an equivalent price per treatment course and noted that the sponsor accepted this in its pre-PBAC response.PSD · Jul 2024
Economic analysis
5.21 As a Category 4 submission, the economic analysis has not been independently evaluated. 4PSD · Jul 2024
5.22 The submission presented a cost-minimisation approach (CMA) of progesterone capsule 300 mg BID compared with progesterone capsule 200 mg TID.PSD · Jul 2024
Clinical claim
5.19 The submission claimed the non-inferior comparative effectiveness and non-inferior comparative safety of progesterone capsule 300 mg BID compared with progesterone capsule 200 mg TID.PSD · Jul 2024
5.20 The PBAC considered that the claim of non-inferior comparative effectiveness and non-inferior comparative safety was reasonable.PSD · Jul 2024
Consumer comments
4.3 The requested amendment for a maximum quantity of 45 pessaries with 3 repeats for Oripro would reduce the number of patient co-payments from 6 to 4. Currently, the total co-payment costs for Oripro is $247.80 for 6 months of treatment (general patient) compared with $165.20 for a general patient on Utrogestan.PSD · Nov 2021
4.7 Based on the requested amendments to the Oripro (prevention of preterm birth) listing, the submission estimated there would be a net cost to the PBS/RPBS of $0 to < $10 million over six years. The loss in average co-payments per patient ($38.43) offsets the save from the reduction in DPMQ per patient (-$13.27). This results in a net cost per patient of $25.16 and hence the net cost to the PBS/RPBS of $0 to < $10 million over six years. 4PSD · Nov 2021

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated by design.

The PBAC could only recommend listing progesterone 300 mg at a higher price than the alternative therapy or therapies if it was satisfied that it provides, for some patients, a significant improvement in efficacy or reduction of toxicity over the alternative therapy or therapies (National Health Act 1953, Section 101(3B)). PBAC · 2024
Price cut / RSA needed ×2

Decision context

PopulationInfertile women undergoing assisted reproductive technology (ART) treatment cycles requiring luteal phase support, from embryo transfer until implantation confirmed by positive B-hCG measurement.

Submission history

8 entries
DecidedOutcomeComparatorICEREvidence
Jul 2024 Recommended · restricted progesterone capsule 200 mg three times daily Cost-minimisation · Cost-minimisation
Jul 2022 Recommended · restricted Crinone 8% (90 mg) progesterone vaginal gel RCT · Clinical pregnancy
Nov 2021 Recommended Utrogestan (progesterone 200 mg soft capsule) Cost-minimisation · Cost-minimisation
Nov 2020 Recommended · restricted best supportive care (standard of care) Meta-analysis · Preterm birth
Nov 2020 Recommended · restricted Standard of Care (SOC) Meta-analysis · Preterm birth
Jul 2016 Recommended · restricted progesterone pessary (Oripro) Cost-minimisation · Cost-minimisation
Mar 2016 Not recommended progesterone pessary (progesterone 8% vaginal gel also considered) RCT · Ongoing pregnancy at 12 weeks
Mar 2014 Recommended progesterone gel (Crinone) and progesterone pessaries (Oripro) RCT · Ongoing pregnancy

Consumer voice

Nov 2020

No consumer comments were received for this item. Consumer comments received for Oripro are included in the separate Public Summary Document for Oripro.

The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to infertile women in ART cycles; TGA label includes support during pregnancy beyond luteal phase.